Advanced Diffusion Magnetic reSonance Prostate Imaging for Reducing Extraneous Biopsies (ASPIRE) - Calibration Component (Multi-centre Scanner Calibration) and Validation Component (Multi-centre Validation)

NCT07808528 | Not Yet Recruiting

• 2 other identifiers: 348487MA-TIA24-006
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

Brief Summary

In 2019 the UK National Institute for Health and Care Excellence (NICE) updated its guidelines to recommend Magnetic Resonance Imaging (MRI) for all patients prior to biopsy as it permits the targeted sampling of suspicious lesions rather than blind systematic biopsy, thereby improving detection of clinically significant prostate cancer while avoiding some unnecessary biopsies. However, there is still the major clinical problem of patients who have an 'MRI suspicious' lesion ultimately having no clinically significant cancer on biopsy. It was calculated that even by using MRI, up to 50% of prostate biopsies may be unnecessary. Prostate biopsies carry many risks and burdens for patients so reducing unnecessary biopsies is therefore a critical unmet need in prostate cancer diagnostics. The ASPIRE study has been designed to enable the safe implementation of advanced diffusion MRI into the prostate cancer diagnostic pathway. This study will compare 3 different advanced diffusion MRI sequences, Vascular, Extracellular, and Restricted Diffusion for Cytometry in Tumours (VERDICT), fast-VERDICT or Restriction Spectrum Imaging (RSI) to discover which one is superior in identifying patients who can safely avoid a biopsy. The study is also separated into 3 distinct components. Firstly, there is an optional component which, once these advanced diffusion sequences have been programmed onto MRI scanners, will recruit local volunteers who were already planning to have to routine MRI as a quality assurance measure. Component 1 (Calibration) is concerned with calibrating the same participants scans over more than one site to enable direct comparison of measurements. Patients under active follow up or previously diagnosed cancer should be enrolled in this component. Component 2 (Validation) sees a participant receiving a standard MRI scan as well as the new advanced diffusion sequences to evaluate the new tests against the reference standard without altering the standard-of-care management.

Conditions

Prostate Cancer (Diagnosis)

Keywords

prostate cancer; ASPIRE; VERDICT; RSI; fast-VERDICT; Fractional intracellular volume; Diffusion-weighted imaging; Vascular, Extracellular, and Restricted Diffusion for Cytometry in Tumours; no biopsy; diagnostic

Outcome Measures

Primary Outcomes (1)

• Calibration Component Analysis: The goal is to characterise differences in quantitative MRI metrics between scanners and derive calibration adjustments. For each pair of scanners (e.g., Philips vs Siemens), a scatter plot of VERDICT fIC values (or other

  Calibration Component Analysis: The goal is to characterise differences in quantitative MRI metrics between scanners and derive calibration adjustments. For each pair of scanners (e.g., Philips vs Siemens), a scatter plot of VERDICT fIC values (or other metric) will be examined across all subjects who were scanned on both. We will calculate the mean difference and 95% limits of agreement (Bland-Altman analysis) to quantify bias and variability. A linear regression will be performed, and the regression equation (slope, intercept) will be used as the calibration formula. If needed, higher-order terms or non-linear fit will be considered, but simplicity is preferred. We will also assess the repeatability of measurements on the same scanner (some participants may have had repeat scans on the same machine or two Philips sites, etc.). The outcome of Calibration Component will be reported descriptively. No formal hypothesis test is applicable, but we will note if the inter-scanner difference

  5 years

Secondary Outcomes (4)

• Direct comparison between VERDICT, fast VERDICT, and RSI

  5 years

• Comparison of calibrated vs uncalibrated threshold performance

  5 years

• Subgroup analyses

  5 years

• Negative MRI cohort

  5 years

Study Arms (3)

Optional Scanner Set-Up Component

OTHER

Local Volunteers who were already scheduled for a routine mpMRI who agree to having the advanced diffusion sequences added as a research scan to their planned MRI scan. The research scan will not be used to influence clinical decisions and just to see if the new advanced diffusion sequences are optimised

Procedure: MRI

Component 1 (Calibration)

OTHER

Travelling volunteer study design of patients with confirmed prostate cancer who will agree to have one mpMRI with the added advanced diffusion sequences research scan at their home site of UCLH and then one more mpMRI with the added advanced diffusion sequences research scan at one of four external NHS hospital sites. These research scans will not be used to influence clinical decisions for the participant but will be used to calibrate the new sequences across different scanners at different sites.

Procedure: MRI

Component 2 (Validation)

ACTIVE COMPARATOR

A prospective cohort study at four external sites for participants with suspected prostate cancer to assess and compare the diagnostic performance of VERDICT, fast VERDICT, and RSI when added to standard mpMRI. The results of the advanced diffusion MRI sequences will not be used to direct patient management in the Validation Component. Radiologists and urologists will remain blinded to the VERDICT/RSI findings when making biopsy decisions, to ensure the study does not influence or compromise care.

Procedure: MRI

Interventions

MRI PROCEDURE

The combination of the 3 additional sequences as a part of the research scan will distinguish this intervention from other studies.

Also known as: MRI + VERDICT, fast-VERDICT and RSI scan

Component 1 (Calibration); Component 2 (Validation); Optional Scanner Set-Up Component

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 scheduled for a prostate mpMRI (Optional Component)
• Willing and able to provide written informed consent (Optional Component, Component 1 and Component 2)
• Patients aged ≥18 with a prior mpMRI demonstrating at least one definite lesion suspicious for prostate cancer (Likert or PI-RADS score 4 or 5) and either under active surveillance for previously diagnosed low-risk prostate cancer or awaiting definitive treatment (Component 1)
• Willing and able to undergo multiple MRI scans at different hospitals (Component 1)
• Patients aged ≥18 with clinical suspicion of prostate cancer, who are scheduled for or have just undergone a prostate mpMRI as part of initial diagnostic workup (Component 2)

You may not qualify if:

• Contraindications to MRI (Optional Component, Component 1 and Component 2)
• Inability to provide informed consent (Optional Component, Component 1 and Component 2)
• Prostate biopsy within the last 3 months (Component 1) OR prior prostate cancer diagnosis or treatment (Component 2)
• Inability to travel to partner hospital site (Component 1)
• Contraindication to biopsy (Component 2)

Sponsors & Collaborators

• University College, London: lead
• University College London Hospitals: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Shonit Punwani, s.punwani@ucl.ac.uk

  UCL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shonit Punwani, FRCR/MRCPUK/MBBS/PhD/BSc

CONTACT

0207 679 5033; s.punwani@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The optional component includes a very small cohort of local volunteer patients, at NHS sites (other than UCLH) who are already undergoing a planned, routine MRI will be scanned to optimise the scanner ahead of the calibration component. Component 1 (Calibration) includes a travelling participant cohort of 20 participants who will have one standard of care MRI + research sequences at UCLH then a second scan at another NHS trial site. Component 2 (Validation) consists of 150 participants who will have a SoC MRI before continuing on the normal diagnostic pathway. PIRADS or Likert score 1-2 indicate low suspicion won't undergo immediate biopsy and be managed as per local SoC. PI-RADS or Likert score ≥3 will undergo TRUS guided biopsy of the identified lesion(s) and any appropriate sampling. Lesion from the biopsy drawn on VERDICT, fast-VERDICT and RSI maps to determine accuracy of MRI. Participants who are MRI +ve and biopsy -ve will have a clinical status check in at 12 months

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: September 9, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available 1 year after publication of the main study results.
• Access Criteria: A study steering committee will review all requests for access to the data and will make decisions on whether or not to grant access to bona fide researchers based on the importance of the research question being asked, ensuring analysis is non overlapping with existing analyses and planned analyses.

Locations

GB (1)